1naEqka
1naEqka
1naEqka
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−<br />
any missing translation names must be provided in all the applicable national languages based<br />
on the process described in section 1.4. of this document. See also Table 1a- Authorised<br />
Medicinal Product – language requirements for related information.<br />
• Any missing synonym/alias names that are in accordance with internationally recognised reference<br />
sources may be requested by means of the process described in section 1.4. of this document.<br />
Only approved substances can be referenced in a pharmaceutical product within an<br />
Authorised Medicinal Product entry.<br />
The substance name used in the pharmaceutical product must be in line with the substance name used<br />
in the SmPC, irrespectively of any symbols, commas, additional brackets, hyphens etc. Please see<br />
NOTE 9 for further information.<br />
• If the substance name was previously successfully submitted in the XEVMPD and a substance EV<br />
Code has been assigned, the substance name can be selected from the available EudraVigilance<br />
look-up table (EVWEB users). Gateway users should populate the 'Excipient substance code' field<br />
(PP.EXC.1) with the assigned substance EV Code.<br />
List of approved substances with the assigned EV Codes is available as part of the Controlled<br />
Vocabulary (CV) lists published on the Agency's website (see "Extended EudraVigilance product<br />
report message substances").<br />
NOTE 13<br />
The XEVMPD look-up table contains the most up-to-date data as substance information is<br />
submitted to the XEVMPD on daily basis. The published XEVMPD substance controlled vocabulary<br />
list contains substances available at the time of publication.<br />
• If the requested excipient substance does not exist in the XEVMPD look-up table/available<br />
Controlled Vocabulary (CV) list "eXtended Eudravigilance Product Dictionary (XEVMPD) substances"<br />
published on the Agency's website, the substance information can be added using the substance<br />
section of the XEVPRM.<br />
See section 1.4. of this document for further information on how to submit an approved substance<br />
in the XEVMPD.<br />
EXAMPLE 58<br />
The SmPC of a medicinal product authorised in Germany states the following information:<br />
6.1 Liste der sonstigen Bestandteile<br />
Wasser für Injektionszwecke<br />
The excipient substance (i.e. EV code of the excipient substance in the local language) to be referenced<br />
in the pharmaceutical product section of the AMP entry in the XEVMPD must be "Wasser für<br />
Injektionszwecke" (in German language).<br />
Detailed guidance on the electronic submission of information on medicinal products<br />
for human use by marketing authorisation holders to the European Medicines Agency in<br />
accordance with Article 57(2) of Regulation (EC) No. 726/2004<br />
EMA/135580/2012 Page 90/163
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